Magnetic Resonance Imaging of Injectate in Thoracic 2 Paravertebral Block

NCT05141136 | Unknown DMC

• 1 other identifier: 3-2021-0293
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to analyze the spread of local anesthetic using magnetic resonance imaging after thoracic 2 paravertebral block in patients with cervical radiculopathy.

Conditions

Cervical Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

• Injectate spread on MRI imge

  Presence of injectate on each anatomic target (Paravertebral space, ventral/dorsal epidural space, intercostal nerve, contralateral space)

  1 hour after thoracic 2 paravertebral block

Secondary Outcomes (8)

• numeric rating score

  Before nerve block, after 30 minutes, and thereafter, at the outpatient visit on the 7th day and the outpatient visit on the 28th day.

• perfusion index

  Before nerve block, after 30 minutes

• skin temperature

  Before nerve block, after 30 minutes

• pinprick and cold test

  Before nerve block, after 30 minutes

• Blood pressure in mmHg

  Before nerve block, after 30 minutes

Study Arms (2)

Ultrasound probe sagittal group

EXPERIMENTAL

A thoracic 2 paravertebra block is performed with the ultrasound probe placed sagittal and the needle in plane with respect to the probe.

Procedure: Ultrasound probe sagittal group

Ultrasound probe transverse group

ACTIVE COMPARATOR

A thoracic 2 paravertebra block is performed with the ultrasound probe placed transverse and the needle in plane with respect to the probe.

Procedure: Ultrasound probe transverse group

Interventions

Ultrasound probe sagittal group PROCEDURE

Place the ultrasound probe vertically against the patient's spine and insert the needle in-plane. The width of insertion of the needle is usually approximately 5 cm from the midline. After the needle penetrates the superior costovertebral ligament and pops, when it reaches the thoracic paravertebral space, perform aspiration and inject 10 mL of 1% lidocaine. At this time, it can be observed in real time as the infusion fluid pushes the bright pleura away from the needle.

Ultrasound probe sagittal group

Ultrasound probe transverse group PROCEDURE

Place the ultrasound probe transverse to the spine and insert the needle in-plane. The reflection of a transverse process is a common landmark. The needle goes in from lateral to in plane. The goal is a triangle between the parietal pleura anteriorly and the internal intercostal membrane and intercostal muscle posteriorly. The final point of the needle is the transition zone from the intercostal to the thoracic paraspinal space, just anterior to the transverse process. When it is confirmed that the tip of the needle has reached the paravertebral space, 10 mL of 1% lidocaine is injected after checking the negative pressure, and after confirming the spread of the drug in real time with ultrasound.

Ultrasound probe transverse group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with unilateral radiating pain in the upper extremity whose pain persists for more than 3 months despite conservative treatment
• Diagnosis: cervical degenerative disc disease, cervical foraminal stenosis, cervical stenosis with/without myelopathy
• Numeric rating score ≥ 4
• years or older

You may not qualify if:

• Cervical or upper thoracic spine surgical history
• If the body mass index is 35 kg/m2 or more
• If you have an allergy or hypersensitivity reaction to a local anesthetic
• coagulation disorders
• Local infection at the injection site
• claustrophobia
• If you have a metal insert such as a pacemaker
• pregnancy
• Patients who are unable to communicate and have cognitive impairment
• If a person who cannot read the consent form is included among the subjects (e.g., illiterate, foreigners, etc.)

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

Gangnam Severance Hospital

Seoul, South Korea

Location

Central Study Contacts

Do Hyeong Kim

CONTACT

82-2-2019-4601; BREADFANS@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Medical staff performing patient care, including pain management, and investigators who investigate and record observations and evaluations, and those who analyze magnetic resonance imaging, are kept unaware of group assignments.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patients with chronic cervical radiculopathy due to degenerative spinal disease for more than 3 months

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: December 2, 2021
• Study Start: November 30, 2021
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: December 2, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)